Pulmonary EmbolismInSPECT-DECTNCT02890706
Iodine Mapping Using Subtraction in Pulmonary Embolism CT Versus Dual-Energy CT
A study testing Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography in people with Pulmonary Embolism, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Comparing two techniques (Subtraction and Dual Energy CT) for functional Chest CT for patients with suspected with pulmonary embolism. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jul 2016to 30 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 35 years or older and able to provide informed consent
- Clinically requested CTPA because of suspected pulmonary embolism
- Available history and physical examination.
Who cannot join
- Pregnancy
- Hemodynamic instability
- Uncooperative patients.
- Contra-indication to intravenous iodine administration.
- Inability to position the arms above the shoulders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iodine Mapping Using Subtraction in Pulmonary Embolism Computed Tomography Versus Dual Energy Computed Tomography
Comparing two techniques (Subtraction and Dual Energy CT) for functional Chest CT for patients with suspected with pulmonary embolism.
Read the detailed description
Rationale: Iodine mapping of the lung using subtraction imaging in addition to standard computed tomography pulmonary angiography (CTPA) may improve the evaluation of pulmonary embolism (PE) in the same manner as the addition of dual energy computed tomography (DECT) to CTPA.
Objective: To evaluate image quality and accuracy of detection of perfusion defects associated with pulmonary pathology on iodine maps of the lung that are created by two different CT techniques: 1. A standard of care CTPA with DECT and 2. A new technique that subtracts a low radiation dose unenhanced CT from mono-energetic CTPA (subtraction) Study design: A maximum of 375 patients will undergo a standard CTPA with DECT according to local clinical guidelines, to have 30 patients with pulmonary embolism. For the purposes of this study, patients will undergo an additional unenhanced, low-radiation dose chest CT. Standard reconstructions of all scans and DECT iodine maps will be obtained for clinical reporting and subsequent treatment decisions, according to standard clinical routine. For research purposes, selected mono-energetic images will be post-processed using a novel subtraction algorithm to create iodine maps of the lungs. The iodine maps based on the subtraction algorithm will not be used for clinical management, only the additional unenhanced scan will be used in clinical management.
Study population: Patients presenting with a clinical indication for pulmonary CT angiography because of suspected pulmonary embolism. Only adult patients (≥ 35 years) who are able to provide informed consent will be enrolled.
Main study parameters/endpoints:
Main endpoint of the study is presence of perfusion as established by an expert panel with access to all imaging information (including CTPA, subtraction and DECT) and clinical follow-up. Accuracy of DECT and subtraction is established by observers who are blinded to CTPA and clinical data. Presence of iodine density differences in perfusion defects is measured using region of interest (ROI) measurements.
Images will be evaluated for objective and subjective image quality. Patient characteristics, radiation dose, clinical diagnosis, treatment decisions and patient outcome (all cause - and PE related mortality) will be recorded.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
CT imaging is associated with risks related to the use of radiation and iodinated contrast administration. No additional contrast will be used as compared to standard clinical practice as patients will only undergo one CTPA scan. The CT protocol of this study has been carefully designed to have a radiation dose identical or even lower than standard CT protocols for pulmonary embolism detection. The estimated dose-length product (DLP) of standard CTPA with DECT in Meander Medical Centre is 167 mGy-cm (effective dose is 2.4 mSv, using 0,0146 mSv/mGy-cm as a conversion factor). The researchers will expose patients who participate in the study to an estimated additional DLP of 72 mGy-cm due to the unenhanced scan, resulting in an additional estimated effective dose of 1,0 mSv. This implies that the total radiation dose is within the same range as radiation doses of other scans for PE detection in the Netherlands. The additional scan is not obligatory in pulmonary embolism diagnosis, but will be used for clinical evaluation of these patients.
- Conditions
- Pulmonary Embolism
- Being tested
- Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography
- Keywords
- Pulmonary embolism (PE), Dual-Energy CT (DECT), Subtraction imaging
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed TomographyDevice
Compare two techniques of the CT scanner
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Each patient undergo the same CT protocol. Theobservers will observe the detection of the perfusion defects in two different techniques. Receives: Device: Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of perfusion defects as reference standard
After 1.5 year, the radiologists scores the presence of perfusion defects caused by pulmonary embolism as a reference standard.
Measured: 1.5 year
Secondary outcomes (4)
Radiation dose
Measured: Through study completion, an average of 2 months
Clinical diagnosis of Pulmonary embolism: after 6 months follow-up
Measured: Through study completion, after the first inclusion, the patients are followed for half a year.
30-day all cause mortality and PE-associated mortality
Measured: Through study completion, an average of three months
6 months all cause mortality and PE-associated mortality
Measured: Through study completion, an average of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start7 Jul 2016
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monique Brink, MD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890706
- Sponsor's protocol ID
- NL56542.091.16
- Acronym
- InSPECT-DECT
- Status last verified
- Sep 2017
- First submitted
- 12 Jul 2016
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Deak PD, Smal Y, Kalender WA. Multisection CT protocols: sex- and age-specific conversion factors used to determine effective dose from dose-length product. Radiology. 2010 Oct;257(1):158-66. doi: 10.1148/radiol.10100047.
PubMed 20851940van der Molen AJ, Schilham A, Stoop P, Prokop M, Geleijns J. A national survey on radiation dose in CT in The Netherlands. Insights Imaging. 2013 Jun;4(3):383-90. doi: 10.1007/s13244-013-0253-9. Epub 2013 May 15.
PubMed 23673455Remy-Jardin M, Pistolesi M, Goodman LR, Gefter WB, Gottschalk A, Mayo JR, Sostman HD. Management of suspected acute pulmonary embolism in the era of CT angiography: a statement from the Fleischner Society. Radiology. 2007 Nov;245(2):315-29. doi: 10.1148/radiol.2452070397. Epub 2007 Sep 11. No abstract available.
PubMed 17848685Lu GM, Zhao Y, Zhang LJ, Schoepf UJ. Dual-energy CT of the lung. AJR Am J Roentgenol. 2012 Nov;199(5 Suppl):S40-53. doi: 10.2214/AJR.12.9112.
PubMed 23097167Wildberger JE, Klotz E, Ditt H, Mahnken AH, Spuntrup E, Gunther RW. Multi-slice CT for visualization of acute pulmonary embolism: single breath-hold subtraction technique. Rofo. 2005 Jan;177(1):17-23. doi: 10.1055/s-2004-813875.
PubMed 15657816Mayo J, Thakur Y. Pulmonary CT angiography as first-line imaging for PE: image quality and radiation dose considerations. AJR Am J Roentgenol. 2013 Mar;200(3):522-8. doi: 10.2214/AJR.12.9928.
PubMed 23436840Pontana F, Faivre JB, Remy-Jardin M, Flohr T, Schmidt B, Tacelli N, Pansini V, Remy J. Lung perfusion with dual-energy multidetector-row CT (MDCT): feasibility for the evaluation of acute pulmonary embolism in 117 consecutive patients. Acad Radiol. 2008 Dec;15(12):1494-504. doi: 10.1016/j.acra.2008.05.018.
PubMed 19000866Grob D, Smit E, Prince J, Kist J, Stoger L, Geurts B, Snoeren MM, van Dijk R, Oostveen LJ, Prokop M, Schaefer-Prokop CM, Sechopoulos I, Brink M. Iodine Maps from Subtraction CT or Dual-Energy CT to Detect Pulmonary Emboli with CT Angiography: A Multiple-Observer Study. Radiology. 2019 Jul;292(1):197-205. doi: 10.1148/radiol.2019182666. Epub 2019 May 14.
PubMed 31084482
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine Mapping Using Subtraction in Pulmonary Embolism Computed Tomography Versus Dual Energy Computed Tomography
- ClinicalTrials.gov ID
- NCT02890706
- Acronym / sponsor ID
- InSPECT-DECT / NL56542.091.16
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism (PE), Dual-Energy CT (DECT), Subtraction imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing two techniques (Subtraction and Dual Energy CT) for functional Chest CT for patients with suspected with pulmonary embolism.
Detailed description
Rationale: Iodine mapping of the lung using subtraction imaging in addition to standard computed tomography pulmonary angiography (CTPA) may improve the evaluation of pulmonary embolism (PE) in the same manner as the addition of dual energy computed tomography (DECT) to CTPA.
Objective: To evaluate image quality and accuracy of detection of perfusion defects associated with pulmonary pathology on iodine maps of the lung that are created by two different CT techniques: 1. A standard of care CTPA with DECT and 2. A new technique that subtracts a low radiation dose unenhanced CT from mono-energetic CTPA (subtraction) Study design: A maximum of 375 patients will undergo a standard CTPA with DECT according to local clinical guidelines, to have 30 patients with pulmonary embolism. For the purposes of this study, patients will undergo an additional unenhanced, low-radiation dose chest CT. Standard reconstructions of all scans and DECT iodine maps will be obtained for clinical reporting and subsequent treatment decisions, according to standard clinical routine. For research purposes, selected mono-energetic images will be post-processed using a novel subtraction algorithm to create iodine maps of the lungs. The iodine maps based on the subtraction algorithm will not be used for clinical management, only the additional unenhanced scan will be used in clinical management.
Study population: Patients presenting with a clinical indication for pulmonary CT angiography because of suspected pulmonary embolism. Only adult patients (≥ 35 years) who are able to provide informed consent will be enrolled.
Main study parameters/endpoints:
Main endpoint of the study is presence of perfusion as established by an expert panel with access to all imaging information (including CTPA, subtraction and DECT) and clinical follow-up. Accuracy of DECT and subtraction is established by observers who are blinded to CTPA and clinical data. Presence of iodine density differences in perfusion defects is measured using region of interest (ROI) measurements.
Images will be evaluated for objective and subjective image quality. Patient characteristics, radiation dose, clinical diagnosis, treatment decisions and patient outcome (all cause - and PE related mortality) will be recorded.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
CT imaging is associated with risks related to the use of radiation and iodinated contrast administration. No additional contrast will be used as compared to standard clinical practice as patients will only undergo one CTPA scan. The CT protocol of this study has been carefully designed to have a radiation dose identical or even lower than standard CT protocols for pulmonary embolism detection. The estimated dose-length product (DLP) of standard CTPA with DECT in Meander Medical Centre is 167 mGy-cm (effective dose is 2.4 mSv, using 0,0146 mSv/mGy-cm as a conversion factor). The researchers will expose patients who participate in the study to an estimated additional DLP of 72 mGy-cm due to the unenhanced scan, resulting in an additional estimated effective dose of 1,0 mSv. This implies that the total radiation dose is within the same range as radiation doses of other scans for PE detection in the Netherlands. The additional scan is not obligatory in pulmonary embolism diagnosis, but will be used for clinical evaluation of these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Device: Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed TomographyEach patient undergo the same CT protocol. Theobservers will observe the detection of the perfusion defects in two different techniques. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 35 years or older and able to provide informed consent
- Clinically requested CTPA because of suspected pulmonary embolism
- Available history and physical examination.
Key exclusion criteria (5 listed)
- Pregnancy
- Hemodynamic instability
- Uncooperative patients.
- Contra-indication to intravenous iodine administration.
- Inability to position the arms above the shoulders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed TomographyCompare two techniques of the CT scanner | Device | Patients |
Primary outcome
Presence of perfusion defects as reference standard
Time frame: 1.5 year
After 1.5 year, the radiologists scores the presence of perfusion defects caused by pulmonary embolism as a reference standard.
4 secondary outcomes
Radiation dose
Time frame: Through study completion, an average of 2 months
Clinical diagnosis of Pulmonary embolism: after 6 months follow-up
Time frame: Through study completion, after the first inclusion, the patients are followed for half a year.
30-day all cause mortality and PE-associated mortality
Time frame: Through study completion, an average of three months
6 months all cause mortality and PE-associated mortality
Time frame: Through study completion, an average of three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 20851940Deak PD, Smal Y, Kalender WA. Multisection CT protocols: sex- and age-specific conversion factors used to determine effective dose from dose-length product. Radiology. 2010 Oct;257(1):158-66. doi: 10.1148/radiol.10100047.
- Background: PubMed 23673455van der Molen AJ, Schilham A, Stoop P, Prokop M, Geleijns J. A national survey on radiation dose in CT in The Netherlands. Insights Imaging. 2013 Jun;4(3):383-90. doi: 10.1007/s13244-013-0253-9. Epub 2013 May 15.
- Background: PubMed 17848685Remy-Jardin M, Pistolesi M, Goodman LR, Gefter WB, Gottschalk A, Mayo JR, Sostman HD. Management of suspected acute pulmonary embolism in the era of CT angiography: a statement from the Fleischner Society. Radiology. 2007 Nov;245(2):315-29. doi: 10.1148/radiol.2452070397. Epub 2007 Sep 11. No abstract available.
- Background: PubMed 23097167Lu GM, Zhao Y, Zhang LJ, Schoepf UJ. Dual-energy CT of the lung. AJR Am J Roentgenol. 2012 Nov;199(5 Suppl):S40-53. doi: 10.2214/AJR.12.9112.
- Background: PubMed 15657816Wildberger JE, Klotz E, Ditt H, Mahnken AH, Spuntrup E, Gunther RW. Multi-slice CT for visualization of acute pulmonary embolism: single breath-hold subtraction technique. Rofo. 2005 Jan;177(1):17-23. doi: 10.1055/s-2004-813875.
- Background: PubMed 23436840Mayo J, Thakur Y. Pulmonary CT angiography as first-line imaging for PE: image quality and radiation dose considerations. AJR Am J Roentgenol. 2013 Mar;200(3):522-8. doi: 10.2214/AJR.12.9928.
- Background: PubMed 19000866Pontana F, Faivre JB, Remy-Jardin M, Flohr T, Schmidt B, Tacelli N, Pansini V, Remy J. Lung perfusion with dual-energy multidetector-row CT (MDCT): feasibility for the evaluation of acute pulmonary embolism in 117 consecutive patients. Acad Radiol. 2008 Dec;15(12):1494-504. doi: 10.1016/j.acra.2008.05.018.
- Derived from this study: PubMed 31084482Grob D, Smit E, Prince J, Kist J, Stoger L, Geurts B, Snoeren MM, van Dijk R, Oostveen LJ, Prokop M, Schaefer-Prokop CM, Sechopoulos I, Brink M. Iodine Maps from Subtraction CT or Dual-Energy CT to Detect Pulmonary Emboli with CT Angiography: A Multiple-Observer Study. Radiology. 2019 Jul;292(1):197-205. doi: 10.1148/radiol.2019182666. Epub 2019 May 14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique Brink, MD study chair
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography in people with Pulmonary Embolism, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of perfusion defects as reference standard (time frame: 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890706, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.